EU new regulations on biocides to take effect in July

The European Commission has promulgated the new legislation on biocides, the European Union's Biocide Regulations (528/2012), which covers the registration of biocides including non-agricultural products. The new regulations will take effect on July 17 and will take effect from September 2013. From the 1st to apply to all EU member states, will replace the "EU Substances Directive" (98/8). After three years of negotiations, the new regulations finally reached an agreement in May. The introduction of the new regulations will make the registration requirements for biocides more stringent.

The previously approved active ingredient of the 98/8 Directive can still be listed until the license expires and the active ingredient review that has already been carried out will continue. The planned completion date is May 14, 2014. As with the new agrochemical product regulations, the approved active ingredients of the biocide will be removed from the annex to the regulation, and a new list of approved active ingredients will be prepared and updated as needed. Currently Annex I of the new regulations contains approved “low-risk active ingredients”. Products containing such active ingredients are eligible to apply for a simplified approval process. This list currently includes a small portion of rodenticide and carbon dioxide.

Annexes 2 and 3 respectively provide registration requirements for active ingredients and formulated products, with separate listings of chemical substances and microorganisms. Annex 4 sets out the corresponding requirements for applicants wishing to dispense with data submissions. For exposures, data may be exempt from submission if there is no scientific necessity or technical feasibility. Annex 5 lists the types of products covered by the regulations, and Annex 6 sets out the general principles for management to evaluate applications.